AzTrials
AzTrials

CholelithiasesNCT06311305

Does Early Laparoscopic Cholecystectomy After ERCP Reduce the Risk of Complications

A study testing Early Laparoscopic cholecystectomy in people with Cholelithiases, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985. Read more about this study

Who is it for?
Ages 15 to 70 years
Conditions the study is for
Cholelithiases
What is being tested?
Early Laparoscopic cholecystectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Mar 2024to 20 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients post ERCP with gall stone.
  • Age 15-70
  • Gender female and male patient.

Who cannot join

  • Post ERCP pancreatitis
  • Septicemia
  • Hepatocellular jaundice and End stage liver disease
  • Patient who didn't give informed consent.
  • Patients who refused laparoscopic cholecystectomy.
  • Patients who were not fit for general anesthesia due to various medical illnesses.
Show all 9Show fewer
  • ERCP for reasons other than stone disease,
  • Contraindications to Laparoscopic cholecystectomy like: Cardiovascular andpulmonary disease, coagulopathies and end-stage liver disease (ESLD).
  • Patients with Carcinoma Gall bladder, Common bile duct strictures, Coagulopathy, previous upper abdominal surgeries

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Sohag University

    Sohag, 82511

    Abdulla M Ahmed, master, 01006546957 ext. 002, abdallah_mohamed_ex@med.sohag.edu.eg

    Abdulla M Ahmed, master

    Recruiting

Other trials in Egypt

About this study

Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985.

The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.

Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria.

Read the detailed description

Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985. 1 The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.2 Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria.3 The diagnosis of choledocholithiasis is initially suggested by symptomatology, laboratory tests, and ultrasound (US) findings. Abdominal ultrasound being the most commonly used initial diagnostic tool for suspected biliary stones has a sensitivity of 25-60% and specificity of 95-100%.4 Ultrasound can reliably detect a dilated extrahepatic bile duct, typically a CBD > 6 mm. However, a large study of patients undergoing cholecystectomy found that nearly half of the patients with choledocholithiasis have a nondilated CBD.5 Moreover, the diameter of the extrahepatic bile duct increases with age and older patients may have a normal duct greater than 6 mm. Largely, due to its poor sensitivity, a negative US does not rule out choledocholithiasis. Contrast enhanced computed tomography has a sensitivity of 71-85% and specificity of 88-95% which can further be improved by addition of a hepatobiliary-excreted intravenous contrast agent.6,7 Since the introduction in 1991, Magnetic resonance cholangiopancreatography (MRCP) has emerged as an accurate, non-invasive diagnostic modality for investigating the biliary and pancreatic ducts with sensitivity of 90-100% and specificity of 92-100%.8,9 An impacted biliary stone will appear as a filling defect with a crescent of bile.10 In 1968, ERCP was introduced as a diagnostic tool in the management of biliary and pancreatic diseases.11 With introduction of Endoscopic sphincterotomy, ERCP has now developed as a therapeutic tool with sensitivity of 90% and specificity of 98%.12 ERCP stone extraction is successful 80% - 90% of time using the techniques of sphincterotomy and balloon catheter or Dormia basket stone retrieval.13 Pancreatitis is the most common complication seen after ERCP. ERCP- induced pancreatitis is defined as new or worsened abdominal pain with serum amylase that is greater than three times the upper limit of normal at 24 hours post procedure and requires at least two days of hospitalisation. Although transient elevation of pancreatic enzymes i.e. serum amylase and serum lipase are evident after ERCP.14 Long term complications include papillary stenosis, cholangitis and recurrent choledocholithiasis.15 The introduction of Laparoscopic cholecystectomy has significantly influenced the treatment of patients with gallstones. Currently it is estimated that over 80% of cholecystectomies are performed using the laparoscopic approach. Advantages of laparoscopic cholecystectomy include earlier bowel function, less postoperative pain, improved cosmesis, shorter length of hospital stay, earlier return to full activity and decreased overall cost. Laparoscopic cholecystectomy (LC) preceded by preoperative ERCP remains the cornerstone and most commonly practiced strategy worldwide for the management of coexisting gallbladder and CBD stones.16 According to the literature, the conversion rate for laparoscopic cholecystectomy (LC) after endoscopic sphincterotomy (ES) for choledocholithiasis reaches 20%, when laparoscopic cholecystectomy is performed 6 to 8 weeks afterward3. Also, many Patients waiting to undergo cholecystectomy after ES for CBD stones, experiences recurrent biliary events requiring repeated endoscopic reintervention, emergency cholecystectomy or both which not only have an obvious influence on a patient's well-being, but also appear to be associated with increased difficulty of surgery and a more complicated postoperative course.17.

Cholecystectomy is often performed after ERCP (endoscopic retrograde cholangiopancreatography) for patients with gallstones in the common bile duct. However, cholecystectomy after ERCP may have some risks and complications, such as:

  • Longer operative time and increased bleeding
  • Higher conversion rate to open cholecystectomy
  • Difficulty in achieving the critical view of safety
  • More post-operative drain and longer hospital stay
  • Infection, perforation, pancreatitis, or bile leak. 17.18 Post ERCP cholecystectomy assessment of difficulty is important to reduce the complications , conversion rate , choose of surgery team ,schedule surgery and improve outcomes .There are multiple risk factor associated with post ERCP cholecystectomyhave beenpreviously described in the literature such as age , sex , obesity anatomical variation ,previous surgery , impacted stone etc .Intra operatively, it has been observed that surgeons encountered difficulty while LC post ERCP when there were dense adhesions at calot's triangle, fibrotic and contracted gallbladder,acutely inflamed or cholecysto-enteric fistula etc.19 The risk of complications may depend on several factors, such as the timing of cholecystectomy after ERCP, the presence of a stent in the bile duct, the severity of gallstone disease, and the experience of the surgeon¹²⁴. Therefore, it is important to discuss the benefits and risks of cholecystectomy after ERCP .20
Conditions
Cholelithiases
Being tested
Early Laparoscopic cholecystectomy
Keywords
ERCP, Laparoscopic, cholecystectomy, Gallstones
Medical subject headings
Cholelithiasis, Gallstones

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Laparoscopic cholecystectomyProcedure or surgery

    Also called laparoscopic cholecystectomy

    laparoscopic cholecystectomy early after ERCP with assessing the risks and complications

Study groups in NCT06311305
Study groupRoleWhat they receive
early laparoscopic cholecystectomy after ERCPOtherwe assess the risks and complications of early laparoscopic cholecystectomy after ERCP
Receives: Procedure: Early Laparoscopic cholecystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bile leakage

    yes or no

    Measured: 2 weeks postoperative

  2. operative time

    in hours

    Measured: intraoperative

  3. intraoperative bleeding

    in cubic centimeters

    Measured: intraoperative

  4. sepsis

    yes or no

    Measured: 2 weeks postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion20 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
we aim to assess if the early laparoscopic cholecystectomy after ERCP can reduce the risks or complications
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06311305
Sponsor's protocol ID
Soh-med-24-03-07MS
Status last verified
Mar 2024
First submitted
6 Mar 2024
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Early Laparoscopic cholecystectomy in people with Cholelithiases, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abdulla M Ahmed, Master (01099696698 ext. 002, abdallah_mohamed_ex@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bile leakage (time frame: 2 weeks postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in